Background
Methods
Patient population
Study design
Treatment
Follow-up
Statistical analysis
Results
Arm 1 | Arm 2 | |
---|---|---|
N | 57 | 67 |
Age (years) | ||
Median (range) | 64 (51–75) | 66 (50–76) |
Gleason score | ||
≤7 | 49 (86%) | 64 (95%) |
>7 | 8 (14%) | 3 (5%) |
cT-stage | ||
<T2c | 11 (19%) | 12 (18%) |
≥T2c | 46 (81%) | 55 (82%) |
iPSA | ||
≤20 ng/ml | 40 (70%) | 57 (85%) |
>20 ng/ml | 17 (30%) | 10 (15%) |
PTV volume | ||
PTVP ± SE (cc) | 116 ± 35 | 116 ± 31 |
PTVSV ± SE (cc) | 92 ± 25 | 92 ± 17 |
PTVLN ± SE (cc) | 608 ± 89 | 613 ± 102 |
Bladder | ||
Total volume ± SE (cc) | 139 ± 94 | 125 ± 60 |
V52.6% ± SE (cc) | 101 ± 54 | 113 ± 51 |
V65.8% ± SE (cc) | 71 ± 35 | 79 ± 30 |
V78.9% ± SE (cc) | 47 ± 20 | 51 ± 19 |
V92% ± SE (cc) | 31 ± 12 | 34 ± 13 |
V100% ± SE (cc)* | 16 ± 8 | 20 ± 12 |
Rectum | ||
Total volume ± SE (cc) | 70 ± 16 | 69 ± 17 |
V52.6% ± SE (cc)* | 43 ± 12 | 54 ± 15 |
V65.8% ± SE (cc)* | 30 ± 10 | 37 ± 12 |
V78.9% ± SE (cc)* | 21 ± 7 | 24 ± 9 |
V92% ± SE (cc) | 14 ± 5 | 15 ± 6 |
V100% ± SE (cc)* | 4 ± 4 | 7 ± 5 |
Acute toxicity
Group | Max GU toxicity | Max GI toxicity | |||||||
---|---|---|---|---|---|---|---|---|---|
Grade | 0 | 1 | 2 | 3 | 0 | 1 | 2 | 3 | |
Arm 1 | 10 (18%) | 31 (54%) | 12 (21%) | 4 (7%) | 16 (28%) | 18 (32%) | 23 (40%) | 0 (0%) | |
Arm 2 | 8 (12%) | 43 (64%) | 11 (16%) | 5 (7%) | 17 (25%) | 24 (36%) | 26 (39%) | 0 (0%) | |
Fisher’s test p | NS | NS | NS | NS | NS | NS | NS | - | |
GU toxicity at week 12
|
GI toxicity at week 12
| ||||||||
Arm 1 | 28 (55%) | 21 (41%) | 2 (4%) | 0 (0%) | 36 (71%) | 8 (16%) | 7 (13%) | 0 (0%) | |
Arm 2 | 46 (85%) | 7 (13%) | 1 (2%) | 0 (0%) | 48 (89%) | 4 (7%) | 2 (4%) | 0 (0%) | |
Fisher’s test p | 0.001 | 0.002 | NS | - | 0.027 | NS | NS | - |
Quality of life
Time points | Baseline | 1 month | 2 months | 3 months | p-value (ANOVA) | |||
---|---|---|---|---|---|---|---|---|
Arm | 1/2 | 1 | 2 | 1 | 2 | 1 | 2 | |
N
|
=124
|
=55
|
=67
|
=54
|
=56
|
=51
|
=54
| |
Urinary domain | 91.9 | 84.3 (2.0) | 81.0 (1.9) | 81.9 (2.0) | 81.7 (2.2) | 87.5 (1.8) | 91.1 (1.8) | 0.5470 |
Function | 97.5 | 91.3 (1.7) | 92.1 (1.5) | 91.6 (18) | 90.6 (1.8) | 95.3 (1.6) | 95.4 (1.5) | 0.8058 |
Bother | 87.9 | 79.4 (2.5) | 73.0 (2.6) | 75.0 (2.6) | 75.4 (3.0) | 82.0 (2.4) | 87.9 (2.4) | 0.4913 |
Incontinence | 97.1 | 94.8 (1.4) | 93.8 (1.5) | 93.7 (1.6) | 91.7 (2.1) | 96.6 (1.6) | 95.6 (1.7) | 0.8293 |
Irritative/obstructive | 89.5 | 79.2 (2.6) | 74.7 (2.5) | 76.5 (2.6) | 77.0 (2.8) | 83.3 (2.3) | 88.1 (2.3) | 0.4556 |
Bowel domain | 95.8 | 82.7 (2.7) | 80.1 (2.5) | 84.1 (2.8) | 78.1 (3.2) | 89.7 (2.6) | 92.6 (1.7) | 0.9208 |
Function | 95.6 | 82.3 (2.6) | 77.1 (2.6) | 83.7 (3.0) | 76.6 (3.2) | 89.3 (2.8) | 91.0 (2.1) | 0.7569 |
Bother | 95.8 | 82.7 (2.7) | 80.1 (2.5) | 84.1 (2.8) | 78.1 (3.2) | 89.7 (2.6) | 92.6 (1.7) | 0.9208 |
N
|
=121
|
=53
|
=66
|
=53
|
=55
|
=50
|
=53
| |
Sexual domain | 28.6 | 22.1 (2.4) | 22.0 (2.9) | 26.1 (3.0) | 26.1 (3.1) | 23.2 (3.2) | 24.2 (3.4) | 0.3919 |
Function | 16.0 | 8.6 (2.8) | 8.1 (3.2) | 11.1 (3.2) | 11.3 (3.4) | 9.5 (3.3) | 10.4 (3.9) | 0.6457 |
Bother | 56.9 | 52.4 (5.0) | 53.2 (4.9) | 59.9 (5.9) | 59.4 (6.3) | 54.0 (5.7) | 55.3 (6.0) | 0.3805 |
Hormonal domain | 83.9 | 83.6 (1.8) | 84.7 (1.3) | 86.2 (1.8) | 83.5 (2.0) | 85.1 (2.2) | 86.5 (1.9) | 0.9304 |
Function | 75.9 | 76.0 (2.7) | 77.7 (2.4) | 79.0 (2.6) | 75.4 (3.6) | 77.3 (2.9) | 80.6 (2.6) | 0.9012 |
Bother | 90.5 | 90.0 (1.3) | 90.5 (1.1) | 92.3 (1.5) | 90.2 (1.6) | 91.7 (2.0) | 91.5 (2.0) | 0.7273 |
Group | Urinary domain | Bowel domain | ||||
---|---|---|---|---|---|---|
Month | Month | Month | Month | Month | Month | |
1 | 2 | 3 | 1 | 2 | 3 | |
Arm 1 | 40% | 59% | 37% | 53% | 48% | 29% |
Arm 2 | 57% | 54% | 20% | 66% | 61% | 28% |
t-test | p = 0.045 | NS | p = 0.002 | NS | NS | NS |